SUMMIT,
NJ
US
Posted: 07/05/2022
2022-07-05
2022-09-10
Job Number: 21008538
Job Description
QA SHOP FLOOR SPECIALIST
SUMMIT, NJ
Work Schedule: 12 hour shifts with split week including one weekend day, Sun - Wed/2nd shift (4pm - 4am) or Wed - Sat/2nd shift (4pm - 4am).
Onsite position.
Project Description:
- The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with the Client's policies, standards, procedures, and Global cGMP.
- Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.
- Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities make improvements and resolve issues.
- Ensure manufacturing compliance with applicable procedures and batch records.
- Perform real time review of manufacturing batch records.
- Review manufacturing shop floor documentation.
- Issue production batch records and product labels to Operations.
- Routinely recognizes and resolves Quality issues - informs management of proposed solutions.
- Seeks management guidance on complex issues.
- Develops procedures.
- Proposes solutions for complex issues and works with management to resolve.
- Follows established procedures and performs work as assigned.
- Builds relationships internally within and with cross functional teams.
- Contributes to goals within the work group.
- Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used.
- Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time.
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
Required Skills:
- Minimum high school diploma required, with equivalent experience.
- Bachelor's degree with 4+ years of relevant work experience preferred
- Aseptic experience preferred, but not required.
- Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
- Background in use of electronic batch record.
- Quality assurance on the shop floor.
- Manufacturing background w/QA background.
- Work in a cleanroom environment.
- Excellent communication skills must have clear, concise speech (will be wearing a mask as part of the cleanroom PPE).
- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Must possess an independent mindset.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
- Work is self-directed.
- Confident in making decisions for non-routine issues.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
- Understands continuous improvement and improves efficiency and productivity within the group or project.
- Able to recognize conflict and notify management with proposed recommendations for resolution.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to effectively multi-task.
- Knowledge of US and global cGMP requirements.
- Excellent verbal and written communication skills.
- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Must be able to work in the cleanroom environment for 6-hour time periods.
- Must be available for weekend and off-shift hours.
- Must be flexible for shift hour changes to support manufacturing.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Purvi: purvi@alphaconsulting.Com
ALPHA'S REQUIREMENT #22-02049
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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